Requirements relating to Serial Number and Lot Number

[Sue789]

Where can I find the requirements of when to use a serial number against a lot number? The parts have no electrical components, not sterilized do not require servicing or installation. Have a use life of six months.

I am working with a Company who is placing three serial numbered parts into one box for shipping. We outsource manufacturing and we distribute the product. At the moment our Warehouse is opening the boxes to find out what serial numbers enclosed. Our subcontractor is unhappy to print another bar code to add to the outside of the box.

We currently have both serial number and lot numbers on the device which is housed in a plastic injection moulded case and contains a dial gauge (no serial number) which is not calibrated and connected to an oxygen supply.

Thanks in advance.
Sue

 

[Mark Meer]

The extent of identification & traceability measures you need to employ is tied to risk.
Does your device have any of the following characteristics?:
1. Implantable?
2. Intended to support or sustain life?
3. Failure would reasonable expect to result in significant injury?

If none of the above, the traceability you institute is up to your own risk-assessment.

Also, it's not totally clear as to the system you describe. Do I have this right:
1. Device includes 3 serialized parts that you do not label (they are labelled by the manufacturer), and additionally, the box they are packaged in has an identifier (also included by the manufacturer)?
2. This box is then included in a plastic case, along with a dial and oxygen-supply, which you label with a serial number and lot?

 

[Sue789]

Thanks for your reply.

The device has none of the characteristics listed above. I am new to the Company and I could not understand why the product required a label and it is my suggestion to remove it after we did an initial risk analysis on the product. Our manufacturer is prepared to lots of 50 which is sufficient for traceability.

The product is labelled with a serial number, lot number and bar code and placed in a box with the same details. These are then packaged in threes and the manufacture is not willing to stick a barcode with the serial numbers on the outside of the shipping box so our Goods-Inwards have to open all the boxes. Which as this is a new product is something we are trying to stop.

 

[Ronen E]

Just a quick note that it's very important to state where it all happens, for regulatory compliance.
- Where is the OEM located?
- Where are the devices initially sent to (receiving warehouse of the OBL)?
- In what market are the devices to be placed by the OBL?

When I say "where" I mean in what regulatory geographical domain (EU, USA etc.).

 

[Sue789]

Thanks for the reply all companies are based in the U.K.

We ship worldwide- USA, Europe, Japan South America, Middle Eat etc.b

 

[Ronen E]

We ship worldwide- USA, Europe, Japan South America, Middle Eat etc.

If you only have one version for all these markets, you'll have to make sure your labeling meets the regulatory requirements in all of them.

 

[Mark Meer]

The device has none of the characteristics listed above. I am new to the Company and I could not understand why the product required a label and it is my suggestion to remove it after we did an initial risk analysis on the product. Our manufacturer is prepared to lots of 50 which is sufficient for traceability.

From what you describe, I'd agree with this assessment.

It sounds like the parts received would be part of your purchasing and supplier control processes, and so I don't see why you'd have to maintain documentation of the serial numbers of all the parts received.

If you maintain purchasing records, and the supplier, in turn, has their own lot/distribution records (presumably as part of an established quality system), then I don't see any reason why you'd have to open every box just to record the serial numbers.